EP1921993A1 - Assembly for receiving body fluids, and method for the production thereof - Google Patents

Abstract

Disclosed is an assembly for receiving body fluids, comprising a sample taking element (10) that is provided with an area (12) for collecting body fluid obtained with the aid of a puncture. The collecting area is formed by a longitudinal slot (12) which is elongate as a capillary tube and is open on both sides via lateral holes (28,30) on the sample taking element (10).

Description

Arrangement for receiving body fluids and manufacturing method thereof

description

The invention relates to an arrangement or device for receiving body fluids such as blood, with a preferably provided with a piercing member for piercing a body part sampling element having a collecting area for collecting obtained by a puncture body fluid, and with a on the collection area with body fluid acted upon, preferably provided with a test field for an analyte in the body fluid sample receiving element. The invention further relates to a method for producing such a sampling element.

An applicant's earlier application PCT / EP2005 / 002357 describes an arrangement for collecting body fluid for analysis purposes, especially for blood glucose concentration determination. This results in a piercing element having a collecting zone for receiving body fluid, wherein the collecting zone can be formed by lateral openings. The liquid transfer can thus take place perpendicular to the piercing direction on a brought into fluidic contact sample receiving element, so that a capillary transport can be avoided via macroscopic routes with high dead volume.

Proceeding from this, the object of the invention is to further develop the systems known from the prior art and to optimize an arrangement of the type specified in the introduction in order to improve the sample intake, whereby an aim of the invention also consists in a simplified production. To solve this problem, the combination of features specified in the independent claims is proposed. Advantageous embodiments and modifications of the invention will become apparent from the dependent claims.

The invention is based on the idea of achieving the most reliable capillary sample taking possible through a capillary slot that is open on both sides. Accordingly, it is proposed according to the invention that the collecting area is formed by a longitudinal slot open on both sides of the sampling element as a capillary, the longitudinal slot being separated from the sample receiving element in a collection position of the sampling element so that no body fluid is transferred, and in a transfer position of the sampling element is in fluidic contact or fluidic connection with the sample receiving element. Thus, a rapid sample uptake can be ensured from both sides in a uniform volume, whereby due to the capillary action no external active action is required. Particularly preferably, the slot extends in the longitudinal or lancing direction of a sampling element designed as a lancing element. It is also conceivable, however, a sample holder after generation of a puncture by means of a separate lancing device. Compared to tubular or semi-open capillaries, the open slot design further reduces the risk of tissue blockage blockages. In addition, the further sample handling can be substantially improved by opening on both sides, whereby a largely dead volume-free transfer can be achieved. For a further integration also in terms of analysis, the sample receiving element provided with body fluid via the collecting area, preferably provided with a test field for an analyte in the body fluid, is provided. This allows a fast and largely lossless liquid transfer to the previously separate receiving element to allow the analysis at a defined time. According to a preferred embodiment of the invention, the length of the longitudinal slot is dimensioned such that in a collection position of the sampling element, the longitudinal slot is partially within and partially outside of the body part. In this way, a venting function of the slot can be achieved in the liquid intake, and there is additional collection volume available. In this regard, it is advantageous if, during the collection of the body fluid, the longitudinal slit has a distal receiving section projecting into the skin of the body part and a proximal vent section located outside the skin.

Advantageously, the longitudinal slot has a length of 0.5 to 4 mm, preferably 1 to 2 mm and a width of less than 500 microns, preferably less than 100 microns. Further, it is advantageous if the longitudinal slot is arranged at a distance of preferably from about 50 to 200 .mu.m to a piercing member forming the distal tip of the sampling element.

In order to reduce the pain felt during a puncture and at the same time to create a sufficient receiving volume, the sampling element can have a cross-sectionally tapered distal shaft section and a cross-sectionally enlarged proximal shaft section in the region of the longitudinal slot.

A further improvement in this direction is achieved in that the longitudinal slot in the collecting position of the sampling element is spatially and / or fluidically separated from the sample receiving element and coupled in a transfer position of the sampling element with the sample receiving element for transfer of body fluid via a side opening. It is also advantageous if the side opening of the longitudinal slot opposite the outlet is connected in a transfer position to an actuator for the active transfer of the body fluid to the sample receiving element.

Advantageously, the actuator acts via pneumatic and / or mechanical displacement means on the body fluid located in the longitudinal slot, wherein a mechanical actuator may be formed by a deformable against the longitudinal slot membrane. It is also favorable if the actuator has a compressed air passage which can be coupled to the side opening of the longitudinal slot facing away from the sample receiving element.

For as complete a fluid transfer as possible, it is advantageous if the sample receiving element has an at least comparably large or larger capillary attraction for the body fluid than the longitudinal slot.

A further advantageous embodiment provides that the Probenent- receiving element is mounted movably in a guide relative to the sample receiving element. For reasons of safety and hygiene, it is advantageous if the sample receiving element forms a quiver receiving the sampling element.

Further usage advantages for the user can be achieved by storing a plurality of sampling elements in a first magazine and a plurality of sample receiving elements in a second magazine, wherein the magazines can be connected to one another as separate units for pairwise coupling of the sampling elements and sample receiving elements.

An advantageous realization possibility is that a plurality of sampling elements in a magazine, preferably a drum magazine are axially ejected, and that associated sample receiving elements are preferably arranged upstream of the magazine in the ejection direction in puncture chambers.

The subject of the invention is also a portable blood analyzer for receiving at least one collection device according to the invention, preferably designed as a disposable article.

The invention also encompasses a system for analyzing bodily fluids, such as blood, having a sampling element, preferably provided with a piercing member for insertion into a body part, which has a longitudinal slot open as a capillary and open on both sides as a collection area for collecting body fluid obtained by a puncture and having a sample receiving element preferably provided with a test field for an analyte in the body fluid via the collecting area, wherein an actuator for transferring body fluid from the sampling element to the sample receiving element is provided. In order to take advantage of the two-sided slot openings particularly space-saving, it is advantageous if the actuator from a side opening acts on the body fluid in the longitudinal slot, and that on the side facing away from the sampling element there is a measurement of an analyte in the body fluid, wherein the sampling element is in fluid communication with the sample receiving element in a transfer position via the side opening facing away from the actuator. In such an instrument with preferably disposable elements for liquid processing, a preferably optical measuring unit is provided for detecting an analyte on the test field loaded with body fluid.

In procedural terms, the object mentioned in the introduction is achieved in that a double-sided open in the sampling element Longitudinal slot is formed as a collection area for the body fluid by laser cutting.

It is advantageous if the boundary surface of the longitudinal slot is hydrophilized during laser cutting.

A further improvement provides that the laser energy and / or the travel speed of the laser beam during laser cutting is position-dependent controlled, so that different material thicknesses can be better taken into account.

Advantageously, the machining time during laser cutting is less than 2 s, preferably about 1 s.

Also, for an increased capillary effect, it is advantageous if the boundary edges of the longitudinal slot are formed with an edge angle of less than 100 °, preferably about 90 °.

A further advantageous procedure provides that a sharp lancing member is produced by grinding on the sample removal element, so that the lancing member is delimited by at least one flat cut. It is also advantageous if a wire or a flat strip is processed as a starting material.

In the following the invention will be explained in more detail with reference to the embodiments schematically illustrated in the drawing. Show it

Fig. 1 is a handheld device for blood sugar measurement in a perspective

View;

FIG. 2 shows a lancing element with a longitudinal slot for taking up blood in a perspective view; FIG. 3 shows an integrated measuring arrangement with piercing element and test element in various process steps in perspective;

FIG. 4 a measurement sequence corresponding to FIG. 3 in axial section; FIG.

5 shows a magazine for a blood glucose meter in an exploded view;

6 shows the measuring sequence when using the magazine of Figure 5 in longitudinal section ..;

Fig. 7 is a partial enlargement of Fig. 6c.

The arrangement 1 shown in the drawing comprises at least one sampling element 10 having a collecting area formed as a longitudinal slot 12 for collecting body fluid obtained at a puncture site from a body part 14 and a sample receiving element 16 for blood sugar detection which can be brought into fluid communication with the longitudinal slot.

Fig. 1 shows a portable blood glucose meter 18 for the use of such a measuring arrangement 1 for the so-called "spot monitoring", ie the self-determination of blood sugar concentration at a given time by a subject. For this purpose, the device 18 has an inwardly tapered pad 20 for finger positioning over a piercing opening 22 for the sampling or lancing element 10. The individual device components are activated in a fully automatic measurement sequence, so that in conjunction with a preferably disposable arrangement 1 inserted in the device, the user finally obtains a reading on his current blood glucose level on a display 24 without the need for elaborate handling. In general, with such a system, the measurements on other parts of the body, for example, in less sensitive to pain Arm or abdominal area are made, which come as a body fluid for sampling in addition to capillary blood from the skin and tissue fluid or mixtures thereof come into question.

As can be seen from Fig. 2, the longitudinal slot 12 extends in the longitudinal direction of the shaft-shaped lancing element 10, for example over a length of 1 to 2 mm with a width of 100 to 200 microns. The distance to a piercing member forming the tip 26 may correspond approximately to the slot width. In this way, a capillary receptacle is formed, into which the body fluid which is accessible at the puncture in the body part 14 (FIG. 4) flows in automatically due to capillary action.

The liquid is absorbed on both sides via the opposite side openings 28, 30 of the longitudinal slot 12. Here, the slot length in the lancing direction is dimensioned so that a distal slot portion 32 projects into the skin of the body part 14 and a proximal slot portion 34 is located outside the skin. For pain reduction, the body-engaging distal shaft portion 36 may be "thin," i. In comparison, the proximal shaft section 38 remaining outside the body has an expanded cross-section or a comparatively greater thickness in order to be able to collect a sufficiently large amount of fluid. For example, the amount of liquid corresponding to the slot volume can be 10 to 20 nanoliters, wherein the partial volume of the longitudinal slot 12 located in the body comprises, for example, a volume fraction of 20%.

In the production of such piercing elements 10, a wire is first processed as a starting material in a defined orientation by grinding processes, wherein the differently angled ground surfaces 40, 42 are produced. Then, in this surface structure, the longitudinal slot 12 is expediently inserted into the same processing station while maintaining the rotational orientation by means of a suitably positioned laser. introduced. An important production detail lies in the fact that the laser energy and / or the travel speed of the laser beam are regulated as a function of the cutting position; This makes it possible to design tapered openings or to compensate for different material thicknesses.

For slot penetration only a few movements of the laser beam are necessary, and the processing time can be kept sufficiently short for a mass production, for example in the range of 1 sec. Also, the mechanical tolerances can be kept low, for example in the range of 10 microns, with wall gradients can be reached by almost 90 °. In addition, activated and / or hydrophilic surfaces can be created by suitable laser treatment, in particular under protective gases or special gases, for a coating, which surfaces can be further improved if necessary by a physical or wet-chemical aftertreatment.

The lancets 10 thus created can be oriented in a plastic holder. This can e.g. come from a roll, and by clipping, hot forming, etc., the connection to the lancet can be done in the correct position. The plastic holder may have a coupling piece so that the lancets can be gripped and moved in the device 18.

Fig. 3 shows a unit of sampling element (lancing element 10) and sample receiving element 16. The sampling takes place by reciprocating piercing movement of the lancing element 10, wherein at the proximal shaft portion 44, a suitable drive is positively coupled. The device-receiving element 16, which is held stationary during the lancing process, is part of a sheath-shaped push guide for the lancing element 10 and has a test field 46 for picking up the body fluid 48 previously collected in the longitudinal slot 12. The quiver acting as a linear guide thus encloses the lancing element in one rectangular-flat configuration, wherein the broad sides of the side openings 28, 30 of the longitudinal slot 12 facing. In addition to an advantageous liquid transfer as a protection of the lancing element 10 and a hygienic disposal is ensured.

The piercing element 10 thus fulfills a feeder function as a "shuttle" during sample collection, while the actual detection of the analyte takes place on the sample receiving element 16 not in contact with the body part 14. This can also be provided as a component of a magazine comprising a plurality of compartmentalized compartments 50, which can be used as a consumable item in the device 18 and can be disposed of again with the spent lancing elements. The glucose detection on the test field or reagent carrier 46 can be carried out photometrically by reflection through the transparent cover window 52, so that the blood liquid 48 in the compartment 50 remains hygienically separated from the device parts. Also conceivable are other detection techniques, for example via fluorescence or electrochemical detection.

4, the essential steps of the sample transfer are illustrated in more detail. In the initial position (4a), the piercing element 10 is protected in the magazine compartment 50, which can be sealed at the front by a piercing film. The piercing movement into the body part 14 (for example, a fingertip) is carried out as quickly as possible and motion-optimized for reasons of pain, it being possible, if appropriate, to control a slightly retracted collecting position from the maximum piercing depth. 4b), the distal slot section 32 advantageously protrudes into the interior of the skin, while the proximal slot section 34 outside thereof fulfills a ventilation function. Thus, the blood fluid obtained in the puncture channel can flow into the collecting slot 12 on both sides in a short collecting time and efficiently fill the entire slot volume. In the collection position, the slot 12 of the sample receiving element 16 is spatially so separated, that there is no fluidic connection between them and the detection reagents can not get into the body. This also makes it possible to start the detection process specifically and to evaluate the measurement process as such. For this purpose, according to Fig. 4c), the lancing element 10 is withdrawn again until the upper side opening 28 of the slot 12 passes under the test field 46. This can have a greater capillary attractiveness than the slot 12 for an automatic transfer of the absorbed blood, for example, by a nonwoven structure. However, the liquid transfer is preferably supported by, as shown in FIG. 4d), depressing a membrane 54 as a displacement means for the collected liquid at the lower slot opening 30. The fluid transfer thus takes place over the entire slot length with a short path transversely to the piercing direction of the lancing element 10.

The embodiment shown in FIGS. 5 to 7 also implements this principle, wherein a special magazine and actuation is provided. According to FIG. 5, the lancing elements 10 are stored in a lancet drum 56, on the rear end side of which the coupling pieces 44 protrude for the drive coupling, while the front (distal) end side is sealed by a piercing foil 58. A separate test strip drum 60 can be fitted via insertion slots with test strips 46, which are then shielded by a film 62 and a front cover 64 against the environment in particular against ingress of moisture. The front cover 64 is seated on a hollow drum axis 66, which at the same time forms an air passage 68 for a pneumatic actuation via the shell-side blow opening 70. Due to the separate magazining different requirements can be taken care of. The piercing elements 10 which come into contact with the body can be suitably sterilized in the lancet drum 56 by high-energy radiation, while the radiation-sensitive test chemistry remains protected against external influences in the test strip drum 60 and does not come into physical contact during the piercing process. As can be seen from FIG. 6, the magazines 56, 60 in the installed state are axially coupled on the drum axis 66, so that in each case one lancing element 10 and one test strip 46 are associated with one another. A magazine receptacle 72 within the device 18 enables the compressed air supply to the air passage 68 and the lancing drive of the piercing element 10 respectively coupled to a drive tappet 74 in coaxial alignment with the finger cone 20 (FIG. 6a). During the lancing advance, the actuated piercing element 10 pierces the upstream chamber 76 of the associated test strip 46 and reaches the maximum feed position (line 78 in FIG. 6b) through the cone opening 22 for a distance of about 10 mm. The blood intake via the slot 12 then takes place as described above. Subsequently, during the return movement of the puncturing element 10, the transfer position shown in FIG. 6c is approached, in which the slot 10 is aligned in its forward direction with the test strip 46.

As best seen in the enlarged section of FIG. 7, a targeted transfer of the collected liquid to the test strip 46 is possible in the transfer position. For this purpose, an air blast is triggered via the air passage 68 in the direction of the arrows 80, 82, which impinges the slot 12 on the facing side opening 28, so that the blood fluid is displaced over the opposite side opening 30 onto the test strip 46 and measured there. The glucose detection can then be carried out reflectometrically via a device optics (not shown). Subsequently, the contaminated piercing element 10 is completely withdrawn into the receiving chamber 84 of the drum magazine 56 and brought by drum rotation, the next function pair 10, 46 in readiness.

Claims

claims 1. Arrangement for receiving body fluids such as blood, with a preferably with a piercing member for piercing into a body part (14) provided with sampling element (10), the one Collecting area (12) for collecting body fluid obtained by a puncture, wherein the collecting area is formed by an elongate slot (12) which is elongated as a capillary and is opened on both sides by lateral openings (28, 30) on the sampling element (10); Collection area (12) with Body fluid can be acted upon, preferably provided with a test field (46) for an analyte in the body fluid sample receiving element (16), wherein the longitudinal slot (12) in a collection position of the sampling element (10) from the sample receiving element (16) is separated and in a transfer position of the sampling element (10) is in fluidic contact with the sample receiving element (16). 2. Arrangement according to claim 1, characterized in that the length of the longitudinal slot (12) is dimensioned so that in the collection position of the sampling element (10) of the longitudinal slot (12) partially within and partially outside of the body part (14). 3. Arrangement according to claim 1 or 2, characterized in that the longitudinal slot (12) in collecting the body fluid into the skin of the body part (14) projecting distal receiving portion (32) and located outside the skin proximal vent portion (34). 4. Arrangement according to one of claims 1 to 3, characterized in that the longitudinal slot (12) has a length of 0.5 to 4 mm, preferably 1 to 2 mm and a width of less than 500 microns, preferably less than 100 microns having. 5. Arrangement according to one of claims 1 to 4, characterized in that the longitudinal slot (12) at a distance preferably from about 50 to 200 microns to a piercing member forming the distal tip (26) of the sampling element (10) is arranged. 6. Arrangement according to one of claims 1 to 5, characterized in that the sampling element (10) in the region of the longitudinal slot (12) has a tapered in cross-section distal shaft portion (40) and a cross-sectionally enlarged proximal Shaft portion (42). 7. Arrangement one of claims 1 to 6, characterized in that a side opening (28,30) as an outlet of the longitudinal slot (12) with the sample receiving element (16) can be brought into fluidic contact. 8. Arrangement according to one of claims 1 to 7, characterized in that a side opening (28,30) of the longitudinal slot (12) in the transfer position to an actuator (54; 68) for the transfer of Body fluid is connected to the sample receiving element (16). 9. Arrangement according to claim 8, characterized in that the actuator (54, 68) via pneumatic and / or mechanical displacement means on the in the longitudinal slot (12) located body fluid acts. 10. Arrangement according to claim 8 or 9, characterized in that the actuator is formed by a against the longitudinal slot (12) deformable membrane (54). 11. Arrangement according to one of claims 8 to 10, characterized in that the actuator has a to a side opening (28,30) of the longitudinal slot can be coupled to the compressed air passage (68). 12. Arrangement according to one of claims 1 to 11, characterized in that the sample receiving element (16) has a larger Kapillarattraktion for the body fluid than the longitudinal slot (12). 13. Arrangement according to one of claims 1 to 12, characterized in that the sampling element (10) in a guide (50) relative to the sample receiving element (16) is movably mounted. 14. Arrangement according to one of claims 1 to 13, characterized in that the sample receiving element (16) forms a sampling element (10) receiving quiver. 15. Arrangement according to one of claims 1 to 14, characterized in that a plurality of sampling elements (10) in a first magazine (56) and a plurality of sample receiving elements (16; 46) are stored in a second magazine (60), wherein the magazines (56, 60) as separate units for pairwise coupling of the sampling elements and sample receiving elements are connectable to each other. 16. Arrangement according to one of claims 1 to 15, characterized in that a plurality of sampling elements (10) in a magazine (56), preferably a drum magazine are axially ejected, and that associated sample receiving elements (46) preferably in puncture chambers (76) the magazine (56) are arranged upstream in the ejection direction. 17. A portable blood analyzer for receiving at least one preferably designed as disposable item assembly (1) according to any one of the preceding claims. 18. A system for analyzing body fluids such as blood, comprising a preferably with a piercing member for piercing a body part (14) provided sampling element (10) as a capillary elongated via side openings (28,30) on both sides open longitudinal slot (12) Collecting area (12) for collecting body fluid obtained by a puncture, and having a sample receiving element (16) which can be acted upon by body fluid, preferably with a test field (46) for an analyte, in the body fluid, wherein an actuator ( 54; 68) for transferring body fluid from the sampling element (10) to the sample receiving element (16). 19. System according to claim 18, characterized in that the actuator (54, 68) acts on the body fluid in the longitudinal slot from a side opening (28, 30), and in that on the side of the sampling element (10) remote therefrom Measurement of an analyte in the body fluid takes place. 20. System according to claim 19, characterized in that the sampling element (10) in a transfer position via the side facing away from the actuator (54; 68) side opening with the sample receiving element (16) is in fluid communication. 21. System according to any one of claims 18 to 20, characterized by a preferably optical measuring unit for detecting a Analytes on the loaded with body fluid test field (46). 22. A method for producing a sampling element (10) for receiving body fluids such as blood, in particular for an assembly (1) according to one of claims 1 to 18, wherein a contour is generated by laser processing, characterized in that in the sampling element (10) a longitudinal slot (12) open on both sides is formed as a collecting region (12) for the body fluid by laser cutting. 23. The method according to claim 22, characterized in that the boundary surface of the longitudinal slot (12) is activated during laser cutting for a coating and / or hydrophilized. 24. The method according to claim 22 or 23, characterized in that the laser energy and / or the travel speed of the laser beam laser beam is controlled position-dependent. 25. The method according to any one of claims 22 to 24, characterized in that the processing time during the laser cutting less than 2 s, preferably about 1 s. 26. The method according to any one of claims 22 to 25, characterized in that the boundary edges of the longitudinal slot (12) are formed with an edge angle of less than 100 °, preferably about 90 °. 27. The method according to any one of claims 22 to 26, characterized in that on the sampling element (10), a distal lancing member (26) is generated by grinding, so that the lancing member is limited by at least one flat ground (36). 28. The method according to any one of claims 22 to 27, characterized in that a wire or a flat strip is processed as a starting material.